Effects of Beef Consumption on Skeletal Muscle Protein Homeostasis and Inflammatory Factors in Pre- and Postmenopausal Females

NCT05714462 | Completed

• 1 other identifier: 275449
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

This will be a randomized study to determine if animal-based protein-rich food sources can stimulate greater muscle protein turnover and whole-body protein balance and reduce skeletal muscle inflammatory markers in postmenopausal women compared to vegetarian base protein-rich foods.

Conditions

Menopause Related Conditions

Outcome Measures

Primary Outcomes (1)

• Net change in muscle protein synthesis (% per day).

  Change in net muscle protein synthesis between groups.

  Study meals are eaten for 5 consecutive days.

Study Arms (5)

postmenopausal with normal/overweight BMI that eats primarily beef as their protein source

EXPERIMENTAL

Other: meals consisting of primarily animal protein sources

postmenopausal with normal/overweight BMI that eats vegetables as their protein source

EXPERIMENTAL

Other: meals consisting of plant protein sources

postmenopausal with obese BMI that eats primarily beef as their protein source in study meals

EXPERIMENTAL

Other: meals consisting of primarily animal protein sources

postmenopausal with obese BMI that eats vegetables as their protein source in study meals

EXPERIMENTAL

Other: meals consisting of plant protein sources

premenopausal with normal/overweight BMI that eats primarily beef as their protein source

ACTIVE COMPARATOR

Other: meals consisting of primarily animal protein sources

Interventions

meals consisting of primarily animal protein sources OTHER

an omnivorous diet

postmenopausal with normal/overweight BMI that eats primarily beef as their protein source; postmenopausal with obese BMI that eats primarily beef as their protein source in study meals; premenopausal with normal/overweight BMI that eats primarily beef as their protein source

meals consisting of plant protein sources OTHER

an herbivorous diet

postmenopausal with normal/overweight BMI that eats vegetables as their protein source; postmenopausal with obese BMI that eats vegetables as their protein source in study meals

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Postmenopausal women ages 50-65 (absence of menstruation for at least 12 months).
• Premenopausal women ages 35-45 (presence of normal monthly menstruation for the past 12 months).
• BMI of 20.0 - 34.9 kg/m2.
• COVID-19 negative and/or asymptomatic

You may not qualify if:

• Any substantial musculoskeletal injuries/diseases that have limited daily activities in the past month.
• Unable to stop the use of anti-inflammatory drugs for the week prior to and during study.
• Diagnosed metabolic or hormonal disease (i.e., renal, cardiovascular, thyroid, polycystic ovary syndrome, or type I/II diabetes mellitus).
• Currently pregnant.
• Gave birth or was lactating within previous 12 months.
• Undergone gastric bypass/bariatric surgery.
• Clinically significant weight gain or loss (\>5% change) in the last 12 months.
• Consuming metabolism-altering drugs or medications (i.e., corticosteroids, stimulants, insulin, thyroid medication).
• Unable or unwilling to suspend anti-clotting medications including aspirin use for 5 days prior to Visit 4.
• Participating in \>200 minutes/week of vigorous exercise and/or \>4 days/week of resistance training.
• Unwilling to fast overnight.
• Surgical menopause.
• Having undergone hormone replacement therapy in the last 12 months.

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

Center of Translational Research in Aging and Longevity

Little Rock, Arkansas, 72205, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized cross-sectional controlled trial will be conducted to quantify whole-body and muscle protein turnover and skeletal muscle inflammation following 5-days of consumption of either beef or isonitrogenous plant-based sources of protein in normal/overweight and obese post-menopausal females.

Study Record Dates

• First Submitted: January 26, 2023
• First Posted: February 6, 2023
• Study Start: August 28, 2023
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: May 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)